Overview

CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction

Status:
Active, not recruiting
Trial end date:
2023-05-04
Target enrollment:
Participant gender:
Summary
Background: Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease. Drugs called statins might shrink plaque. Researchers want to study how CT scanning can determine if an individual s arterial plaque has decreased while taking statins. Objectives: To measure the change in coronary artery plaque volume in people treated with high-intensity statin therapy using CT and MRI scans. To study the metabolic activity of plaque in arteries. To determine how well plaque measurements from heart CT scans can be replicated. Eligibility: Men ages 40-75 and women ages 40-75 who are good candidates for statin treatment Design: Visit 1: participants will be screened with: - Medical history - Blood tests - Heart MRI and CT scan: An IV inserted into an arm or hand vein removes blood and injects contrast, and medicine if needed. Participants lie on a table that slides into a machine that takes pictures of the body. For the CT scan, if their heart rate is too high, they get medicine to lower it. They breathe in a special way, holding their breath for 5 seconds. Participants will begin high-intensity statin treatment. Participants will have 7 more visits over 3 years. All visits include blood tests and medication review. Some may also include: - Statin treatment adjustment - CT scan - MRI scan - Physical exam Participants may join the PET Substudy. This includes 5 more visits during the study. These include: - Getting an IV in an arm vein - Blood tests - PET scans: They fast 12 hours before. Participants may join the Reproducibility Substudy if they had a slow heart rate during their first CT scan. This includes 1 additional heart CT scan 4 weeks later.
Phase:
Phase 4
Details
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
Treatments:
Atorvastatin
Atorvastatin Calcium
Rosuvastatin Calcium